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Home » Topics » Regulatory

Regulatory
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Daiichi and Merck pull accelerated approval BLA for ADC

May 29, 2025
By Lee Landenberger
No Comments
Daiichi Sankyo Co. Ltd. and Merck & Co. Inc. have voluntarily pulled the BLA for accelerated approval tied to their HER3-directed antibody-drug conjugate (ADC) in treating EGFR-mutated non-small-cell lung cancer. The partnership in the expanding ADC space began nearly two years ago in a $22 billion deal.
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US trade court blocks emergency tariffs, but threat remains

May 29, 2025
By Mari Serebrov
No Comments
A court decision blocking President Donald Trump’s reciprocal and trafficking tariffs was hardly a day old before the U.S. Court of Appeals for the Federal Circuit stepped in late May 29 to grant a temporary stay while it considers the administration’s appeal. The stay adds further uncertainty to the path ahead for drug and device companies.
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Mitochondria

CRL blocks Barth syndrome drug; Stealth aims to try again

May 29, 2025
By Karen Carey
No Comments
Developing a therapy for an ultra-rare condition has its challenges, including finding enough patients for clinical enrollment and convincing regulatory authorities that limited data prove the candidate is safe and effective. For that reason, Stealth Biotherapeutics Inc. has faced numerous roadblocks getting its mitochondria-targeting elamipretide across the finish line for Barth syndrome, a condition that affects about 230 to 250 males worldwide, including fewer than 150 in the U.S.
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Woman receiving chemotherapy
Endocrine/metabolic

Kexing’s GB-18 receives IND clearances in China and US for cancer cachexia

May 29, 2025
No Comments
Kexing Biopharm Co. Ltd. has announced IND clearances this month by China’s National Medical Products Administration (NMPA) and the U.S. FDA for GB-18, a biologic product for the treatment of cancer cachexia.
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Judge's gavel with US flag

Doctrine of inherent disclosure resurfaces in Zeiss patent dispute

May 28, 2025
By Mark McCarty
The doctrine of inherent disclosure is not one of the more common methods for invalidating patent claims, but this doctrine led the U.S. Court of Appeals for the Federal Circuit to declare that several claims found in a patent held by Carl Zeiss X-Ray Microscopy Inc. are invalid.
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Toy bulldozer moving FDA letter blocks

FDA continues offensive against bogus device test results

May 28, 2025
By Mark McCarty
The U.S. FDA issued general correspondence letters to two device testing labs located in China. This is the latest in a series of moves by the agency to crack down on falsified or otherwise invalid device testing data.
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USTR begins search for biopharma R&D ‘freeloaders’

May 28, 2025
No Comments
The U.S. Trade Representative (USTR) is asking for help in its search for “freeloaders” that refuse to shoulder their share of the cost of biopharma R&D.
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Gavel with whistle

DOJ makes arrests for COVID fraud in excess of $227M

May 27, 2025
By Mark McCarty
The U.S. Department of Justice arrested two men in connection with fraudulently billing the Medicare program for COVID-19 tests, some of which were billed for deceased beneficiaries. The case is notable for its use of foreign nationals recruited to set up non-existent labs to file the claims, seeming to signal a new front in efforts to corral Medicare fraud in the U.S.
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Kennedy welcomes end of COVID-19 vaccines for healthy kids

May 27, 2025
By Mari Serebrov
No Comments
Without convening the U.S. CDC’s Advisory Committee on Immunization Practices, Health and Human Services Secretary Robert Kennedy decided to bring the government’s COVID-19 vaccine recommendations in line with the FDA’s new “evidence-based” approach to the shots.
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Samsung Biologics plant

Samsung Biologics to spin off biosimilar subsidiary Samsung Bioepis

May 27, 2025
By Marian (YoonJee) Chu
No Comments
Samsung Biologics Co. Ltd. plans to establish a new holding company and to spin off its biosimilar division, Samsung Bioepis Co. Ltd., by October. The corporate restructuring will draw clear lines between Samsung Biologics’ CDMO operations and Samsung Bioepis’ biosimilar business.
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